As Rewire previously reported, U.S. District Court Judge Edward R. Korman has made a significant ruling, which will required the Food and Drug Administration (FDA) to allow over-the-counter access to emergency contraception for women of all ages.
The ruling comes after years of legal battles surrounding a prior FDA decision to deny a drugmaker’s application to sell its emergency contraception over the counter, including to minors.
While much attention has focused on the impact this decision will have on women’s access to emergency contraception, few commentators have highlighted the egregious conduct of both the FDA and Department of Health and Human Services Secretary Kathleen Sebelius in handling this issue.
The judgment is littered with scathing descriptions of bad faith, politically-motivated maneuvering, and unbelievable wastes of time and taxpayers’ money as well as jaw-dropping legal mistakes—all of which go well beyond the language one expects to find in typical legal opinions.
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In particular, Judge Korman found that Secretary Sebelius acted for political reasons when, in late 2011, she took the unprecedented step of ordering the FDA to deny the drugmaker’s application, even though the FDA had already made an independent decision that the application should be approved.
“The motivation for the Secretary’s action was obviously political. … And it was an election-year decision that ‘many public health experts saw as a politically motivated effort to avoid riling religious groups and others opposed to making birth control available to girls,’” Judge Korman wrote, quoting this article from the New York Times.
The judge also dished out blistering assessments of the Department of Health and Human Services’s poor use of science, and its inconsistent treatment of emergency contraception when compared to all other classes of drugs.
Here are a few of the stand-out zingers from the decision. Together, they paint a picture of a bumbling and politicized agency, fighting to deprive women of over-the-counter access to emergency contraception, despite a wealth of evidence that supports such access.
On the political nature of Sebelius’ decision:
1. “This case is not about the potential misuse of Plan B by 11-year-olds. These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-olds using these drugs is likely to be miniscule … Instead, the invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.”
2. “This case has proven to be particularly controversial because it involves access to emergency contraception for adolescents who should not be engaging in conduct that necessitates the use of such drugs and because of the scientifically unsupported speculation that the drug could interfere with implantation of fertilized eggs.”
3. “In the present circumstances, the political interference came directly from the Secretary of Health and Human Services, a member of the President’s Cabinet. Of course, the Secretary herself is the best source of information on her state of mind, and she has not seen fit to file an affidavit in this case, even though her motives are in issue.”
4. “Even with eyes shut to the motivation for the Secretary’s decision, the reasons she provided are so unpersuasive as to call into question her good faith.”
On the misuse of science by the FDA and the Department of Health and Human Services:
5. “The agency’s decision [to deny over-the-counter access to emergency contraception] cannot withstand any degree of scrutiny, not only because of its unexplained failure to follow the FDA policies discussed above but also because of its disregard for the scientific evidence that the FDA had before it.”
6. One of the department’s key arguments against offering emergency contraceptives over-the-counter to minors was that minors could not understand the labeling, and may take the medication incorrectly. Korman rejected that argument:
“If the “cognitive differences” to which [Sec. Sebelius] referred affected the ability of the youngest adolescents to understand the label and use the drug appropriately, then it would be impossible for any drug to be approved for over-the-counter sales without a prescription.”
7. “The likelihood of unsafe use or misuse with respect to levonorgestrel-based emergency contraceptives is extremely low, and much lower than the dangers of misuse of common over-the-counter medications that are known to be abused by minors and adults, even though these drugs cause hundreds of deaths every year in the United States.”
For instance, Korman noted, dextromethorphan, which is in over-the-counter cold and flu medication, is widely abused by teenagers looking to get high.
On the true impact of denying over-the-counter access to emergency contraception for women of all ages:
8. The risk of unwanted pregnancy “is especially great for young women and low-income women, two groups that could significantly benefit from timely access to and use of the product,” wrote Judge Korman, quoting a study on access to emergency contraception for adolescents.
9. “The obstructions in the path of those adolescents in obtaining levonorgestrel-based emergency contraceptives under the current behind-the-counter regime have the practical effect of making the contraceptives unavailable without a doctor’s prescription. The basic fact is that most younger adolescents, including ‘many poor or disadvantaged women,’ ‘will be denied access because they do not have a driver’s license, passport, or other form of identification with which to verify their age.’”
On the political game-playing the government engaged in, and its poor legal submissions:
10. Judge Korman berated the FDA for using stalling tactics to slow down the court proceedings, saying it had caused delays so bad that they could be called “an administrative agency filibuster.”
One of the “devices” the agency used was seeking public comments on whether it should engage in an administrative process known as “rule making.”
Here’s what the judge had to say about that “device”:
“After eating up eleven months, 47,000 public comments, and hundreds of thousands, if not millions, of dollars, it decided that it did not need rulemaking after all. The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction.”
11. So bad were some of the government’s legal filings, that Judge Korman chose not to even consider them. In one case, the government cited a 20,000-word document without developing any legal argument, leading Judge Korman to say the following:
“‘Judges are not like pigs, hunting for truffles buried in briefs.’ It is not my job, in a case in which numerous briefs and motions have been filed, to ‘scour through footnotes in search of some possibly meritorious point that counsel did not consider of sufficient importance to [develop or] include as part of the argument.’”